The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for in vitro diagnostic (IVD) device manufacturers dealing with expiring or expired CE certificates. This update aligns with the European Union’s IVDR transitional arrangements, aiming to ensure the continued safe supply of IVDs in the Great Britain (GB) market during the regulatory transition period.
Extended Deadlines for CE-Marked IVDs
Manufacturers can now place CE-marked IVDs compliant with the EU IVDD on the GB market beyond previous deadlines. Specifically, Annex II List A, List B, and self-test IVDs can remain on the market until December 31, 2027. Additionally, general IVDs up-classified to Class D and Class C have extensions until December 31, 2027, and December 31, 2028, respectively. Class B devices enjoy the longest extension, valid until December 31, 2029. These measures provide manufacturers with a clear timeline to transition to the new UK regulatory framework.
Implications for Device Registration
The MHRA encourages manufacturers or their UK Responsible Persons (UKRP) to update their registrations in the MHRA Device Online Registration System (DORS). Detailed guidance has been provided to navigate six different scenarios, including devices already registered and those not yet on the MHRA registry. Additionally, a template for Article 110 extension confirmation is available to facilitate compliance.
Key inferences from the guidance include:
- Manufacturers must proactively update their registrations to avoid disruptions in the supply chain.
- The extensions provide a buffer period for transitioning to the UK’s independent regulatory framework post-Brexit.
- Non-compliance could lead to removal of IVDs from the GB market, impacting healthcare providers and patients.
- Up-classification of IVDs necessitates involvement of a notified body, adding another layer of regulatory compliance.
- The guidance underscores the MHRA’s commitment to maintaining high safety standards during regulatory changes.
The MHRA’s updated guidance ensures that IVD manufacturers have sufficient time to comply with the new UK regulations without compromising the availability of essential diagnostic devices. This strategic extension not only supports the seamless transition to the UK’s regulatory environment but also maintains the integrity and safety of medical device supply chains. Manufacturers should take immediate steps to align their registrations and compliance processes with the new deadlines to sustain their market presence in Great Britain. Engaging with regulatory consultants, such as Emergo by UL, can provide valuable support and ensure adherence to the updated guidelines.
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